MK-7480 Single Ascending Dose Study in Healthy Participants
Key facts
- Where
- Gent, BelgiumSee the site
- Phase
- 1. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Belgium
- Universitair Ziekenhuis GentGent, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- EU 2023-505138-88-00
- Record updated
- 2024. január 18.
- Original description
1. To assess the safety and tolerability of single ascending oral doses of MK-7480 administered to healthy adult male participants 2. To assess the plasma PK of MK-7480 following administration of single ascending oral doses to healthy adult male participantsRead full original descriptionShow less
A Two-Part Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of MK-7480 in Healthy Participants
1. To assess the safety and tolerability of single ascending oral doses of MK-7480 administered to healthy adult male participants 2. To assess the plasma PK of MK-7480 following administration of single ascending oral doses to healthy adult male participants
Inclusion: Be in good health; Body Mass Index (BMI) of 18-32 kg/m2; Assigned male sex at birth; Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or uses a protocol-defined method of contraception; Willing to comply with the study restrictions.
Exclusion: A regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 12 months. Participants must have a negative drug screen prior to randomization; The participant had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit; Has received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention. Exception: COVID-19 or inactivated influenza vaccines may be administered. Study intervention must be given at least 72 hours following or at least 48 hours prior to any COVID-19 or influenza vaccination; Unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 4 weeks prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit; History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases; History of cancer (malignancy); Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV; Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day; Participated in another investigational study within 4 weeks; The participant is a smoker and/or has used nicotine or nicotine-containing products (e.g., nicotine patch and electronic cigarette) within 3 months; Consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.